Dermatitis atopic
Conditions
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent. - Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1). - Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments. - Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1). - Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively). - AD involvement of 10% or more of Body Surface Area (BSA) at baseline (Day 1). - Weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score of >=4 at baseline (Day 1). - Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment. - Known history of, or suspected, significant current immunosuppression. NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percent change in EASI score from baseline to Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants achieving EASI-75 at Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] EASI-75 is defined by reduction of EASI score by >=75% from baseline. 2. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) and a reduction from baseline of >=2 points at Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] The vIGA-AD score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe). 3. Proportion of participants with reduction (improvement) of >=4 in the weekly average of daily PP-NRS score from baseline to Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] The PP-NRS is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable". 4. Absolute change from baseline in EASI score at Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] Refer to the primary outcome-1 for "EASI". 5. Percent change from baseline in EASI score throughout the study [Time Frame: From Baseline throughout the study, up to Week 24] Refer to the primary outcome-1 for "EASI". 6. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] Refer to the secondary outcome-2 for "vIGA-AD". 7. Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from baseline of >=2 points throughout the study [Time Frame: From Baseline throughout the study, up to Week 24] Refer to the secondary outcome-2 for "vIGA-AD". 8. Percent change in the weekly average of daily PP-NRS scores from baseline to Week 24 [Time Frame: From Baseline throughout the study, up to Week 24] Refer to the secondary outcome-3 for "PP-NRS". 9. Percent change in the weekly average of daily Sleep Disturbance-Numerical Rating Scale ( | — |
Countries
Japan, TBD
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed